Kesimpta

What Is Kesimpta?

Kesimpta (ofatumumab) is a CD20-directed cytolytic antibody used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

What Are Side Effects of Kesimpta?

Side effects of Kesimpta include:

• upper respiratory tract infection,
• headache,
• injection-related reactions (fever, headache, muscle pain, chills, and fatigue), and
• local injection site reactions (redness, pain, itching, and swelling)

Dosage for Kesimpta

The initial dosing of Kesimpta is 20 mg administered at Week 0, 1, and 2. Subsequent dosing of Kesimpta is 20 mg administered monthly starting at Week 4.

Kesimpta In Children

Safety and effectiveness of Kesimpta in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Kesimpta?

Kesimpta may interact with other medicines such as:

• immunosuppressant drugs, including systemic corticosteroids.

Tell your doctor all medications and supplements you use.

Kesimpta During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Kesimpta; it is unknown how it might affect a fetus. Kesimpta may cross the placenta and cause fetal B-cell depletion based on findings from animal studies. Females of childbearing potential should use effective contraception while receiving Kesimpta and for 6 months after the last treatment of Kesimpta. It is unknown if Kesimpta passes into breast milk or how it could affect a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Kesimpta (ofatumumab) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Kesimpta Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection or up to 24 hours later. Tell your caregiver right away if you feel dizzy, tired, nauseated, light-headed, feverish, chilled, sweaty, itchy, or have a skin rash, headache, muscle pain, back pain, stomach pain, irregular heartbeats, chest tightness, trouble breathing, or swelling and irritation in your throat.

Ofatumumab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Call your doctor at once if you have:

• pain, redness, swelling, or itching where the medicine was injected;
• right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well;
• a lung infection--fever, chills, cough with mucus, chest pain, feeling short of breath;
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• side effects during an infusion;
• irritation where an injection was given;
• fever, low blood cell counts;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• cough, chest tightness, trouble breathing, lung infection;
• diarrhea, nausea;
• rash; or
• headache, tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Kesimpta (Ofatumumab Injection)

 

Kesimpta Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are discussed in greater detail elsewhere in the labeling:

• Infections [see WARNINGS AND PRECAUTIONS]
• Injection-Related Reactions [see WARNINGS AND PRECAUTIONS]
• Reduction in Immunoglobulins [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Approximately 1500 patients with RMS received KESIMPTA in clinical studies. In Study 1 and Study 2, 1882 patients with RMS were randomized, 946 of whom were treated with KESIMPTA for a median duration of 85 weeks; 33% of patients receiving KESIMPTA were treated for up to 120 weeks [see Clinical Studies]. The most common adverse reactions occurring in greater than 10% of patients treated with KESIMPTA and more frequently than in patients treated with teriflunomide were upper respiratory tract infections, injection-related reactions (systemic), headache, and injection-site reactions (local). The most common cause of discontinuation in patients treated with KESIMPTA was low immunoglobulin M (3.3%), defined in trial protocols as IgM at 10% below the lower limit of normal (LLN).

Table 1 summarizes the adverse drug reactions that occurred in Study 1 and Study 2.

Table 1: Adverse Reactions in Patients with RMS with an Incidence of at Least 5% with KESIMPTA and a Greater Incidence Than Teriflunomide (Pooled Study 1 and Study 2)

Adverse Reactions	KESIMPTA 20 mg N = 946 %	Teriflunomide 14 mg N = 936 %
Upper respiratory tract infectionsa	39	38
Injection-related reactions (systemic)	21	15
Headache	13	12
Injection-site reactions (local)	11	6
Urinary tract infection	10	8
Back pain	8	6
Blood immunoglobulin M decreased	6	2
aIncludes the following: nasopharyngitis, upper respiratory tract infection, influenza, sinusitis, pharyngitis, rhinitis, viral upper respiratory infection, tonsillitis, acute sinusitis, pharyngotonsillitis, laryngitis, pharyngitis streptococcal, viral rhinitis, sinusitis bacterial, tonsillitis bacterial, viral pharyngitis, viral tonsillitis, chronic sinusitis, nasal herpes, tracheitis.

Injection-Related Reactions And Injection-Site Reactions

The incidence of injection-related reactions (systemic) was highest with the first injection (14.4%), decreasing with subsequent injections (4.4% with second, less than 3% with third injection). Injection-related reactions were mostly (99.8%) mild to moderate in severity. Two (0.2%) patients treated with KESIMPTA reported serious injection-related reactions. There were no life-threatening injection-related reactions. Most frequently reported symptoms (2% or greater) included fever, headache, myalgia, chills, and fatigue.

In addition to systemic injection-related reactions, local reactions at the administration site were very common. Local injection-site reactions were all mild to moderate in severity. The most frequently reported symptoms (2% or greater) included erythema, pain, itching, and swelling [see WARNINGS AND PRECAUTIONS].

Laboratory Abnormalities

Immunoglobulins

In Study 1 and Study 2, a decrease in the mean level of IgM was observed in KESIMPTA-treated patients but was not associated with an increased risk of infections [see WARNINGS AND PRECAUTIONS]. In 14.3% of patients in Study 1 and Study 2, treatment with KESIMPTA resulted in a decrease in a serum IgM that reached a value below 0.34 g/dL. KESIMPTA was associated with a decrease of 4.3% in mean IgG levels after 48 weeks of treatment and an increase of 2.2% after 96 weeks.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medication, and the underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other ofatumumab products may be misleading.

Treatment induced anti-drug antibodies (ADAs) were detected in 2 of 914 (0.2%) KESIMPTA-treated patients; no patients with treatment enhancing or neutralizing ADAs were identified. There was no impact of positive ADA titers on PK, safety profile or B-cell kinetics in any patient; however, these data are not adequate to assess the impact of ADAs on the safety and efficacy of KESIMPTA.

Read the entire FDA prescribing information for Kesimpta (Ofatumumab Injection)